K932153 is an FDA 510(k) clearance for the THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME. This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on September 7, 1993, 126 days after receiving the submission on May 4, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K932153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1993 |
| Decision Date | September 07, 1993 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |